Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Gabapentin
Drug ID BADD_D00981
Description Gabapentin is a structural analogue of the inhibitory neurotransmitter gamma-aminobutyric acid ([GABA]) that was first approved for use in the United States in 1993.[L8717] It was originally developed as a novel anti-epileptic for the treatment of certain types of seizures[A186277,A186143] - today it is also widely used to treat neuropathic pain.[A14097,A186179] Gabapentin has some stark advantages as compared with other anti-epileptics, such as a relatively benign adverse effect profile, wide therapeutic index, and lack of appreciable metabolism making it unlikely to participate in pharmacokinetic drug interactions.[A186143,A185981,L8717]. It is structurally and functionally related to another GABA derivative, [pregabalin].
Indications and Usage In the United States, gabapentin is officially indicated for the treatment of postherpetic neuralgia in adults and for the adjunctive treatment of partial-onset seizures, with or without secondary generalization, in patients 3 years of age and older.[L8717] In Europe, gabapentin is indicated for adjunctive therapy in the treatment of partial-onset seizures, with or without secondary generalization, in patients 6 years of age and older and as monotherapy in patients 12 years of age and older. It is also used in adults for the treatment of various types of peripheral neuropathic pain, such as painful diabetic neuropathy.[L8732]
Marketing Status approved; investigational
ATC Code N02BF01
DrugBank ID DB00996
KEGG ID D00332
MeSH ID D000077206
PubChem ID 3446
TTD Drug ID D0J0ZS
NDC Product Code 72789-055; 72888-132; 76420-235; 80425-0031; 80425-0097; 80425-0182; 82009-071; 52133-0025; 62331-031; 64220-211; 69617-002; 71574-121; 71901-609; 16714-332; 25000-103; 42385-974; 43602-466; 49483-607; 51407-047; 0228-2636; 52427-815; 53002-3423; 55289-959; 55700-584; 60687-591; 61919-640; 62756-202; 63187-006; 63187-010; 63187-810; 63629-7666; 63629-8490; 63739-560; 63739-591; 67877-429; 68001-412; 68071-5193; 68382-205; 68788-7822; 68788-7839; 68788-8176; 70010-926; 70518-0810; 70518-1760; 71093-120; 71205-317; 71205-485; 71205-619; 71205-638; 71335-0351; 71335-1007; 71335-1132; 71335-1200; 71335-1269; 71335-1496; 71610-044; 71610-621; 72789-127; 76282-706; 80425-0286; 83301-0002; 45963-556; 57884-0010; 65977-0054; 0071-0803; 16714-504; 42385-972; 43602-470; 50383-311; 50383-351; 51224-219; 51407-048; 51407-049; 52427-850; 53002-1538; 55700-780; 55700-950; 60687-518; 60760-088; 60760-814; 61919-387; 62756-139; 63187-372; 63187-392; 63629-8485; 63629-8487; 63739-236; 65162-102; 65862-524; 67877-428; 68071-3445; 69367-344; 70010-927; 70518-3330; 71093-122; 71205-373; 71205-533; 71335-0073; 71335-1287; 71335-2004; 71610-057; 71610-060; 71610-088; 71610-166; 71610-410; 71610-426; 0615-8132; 0615-8233; 0615-8340; 76420-234; 80425-0128; 83301-0001; 42765-018; 65862-523; 16714-663; 17856-0698; 42806-509; 42806-510; 43353-075; 43353-081; 43353-864; 43602-467; 43602-469; 45865-122; 49483-606; 50090-0949; 50090-3915; 50228-178; 50268-325; 51224-019; 55154-8193; 55154-8195; 59088-725; 59762-5050; 60687-602; 62756-137; 62756-138; 63187-909; 65862-200; 68071-2308; 68071-2600; 68071-2883; 68071-2907; 68462-126; 68788-7838; 68788-8475; 69097-811; 69097-814; 69367-131; 69367-133; 70518-1469; 70518-1544; 70518-2323; 70518-2912; 70518-2970; 70518-3755; 71205-932; 71335-1012; 71335-1655; 71610-198; 72189-394; 53746-101; 55154-3366; 59762-4135; 60760-605; 61919-350; 61919-417; 63187-057; 63629-8488; 63739-902; 64380-867; 68788-7024; 68788-7774; 68788-8468; 68788-8476; 70010-109; 70518-2911; 70518-3708; 71205-766; 71335-0254; 71335-0820; 71335-0993; 71335-1198; 71610-072; 72162-1813; 72189-419; 76420-047; 80425-0158; 82982-049; 82982-067; 17337-0415; 45963-557; 49452-3241; 65862-198; 66651-901; 0071-0401; 68554-0128; 82393-212; 16714-661; 31722-167; 45963-555; 49483-605; 50090-5961; 50228-180; 53002-4423; 55154-7993; 61919-982; 63187-148; 63187-983; 63739-903; 65841-705; 65841-706; 67296-1536; 68071-4978; 69367-134; 69367-135; 69367-346; 70010-118; 70518-3140; 70934-284; 70934-933; 71205-160; 71205-514; 71205-671; 71205-808; 71205-931; 71335-1018; 71335-1991; 71610-090; 71610-188; 72189-392; 0615-8342; 72888-104; 76282-405; 80425-0032; 80425-0033; 80425-0149; 0904-6665; 0228-2637; 65862-199; 68981-009; 71052-176; 0071-2012; 16571-868; 31722-149; 42385-973; 43602-471; 45865-405; 45865-498; 45865-549; 50090-3200; 50090-4445; 50090-4893; 50228-177; 50436-0223; 52427-804; 52427-890; 55700-949; 60760-066; 60760-740; 61919-660; 62207-927; 63187-056; 63187-149; 63187-248; 63629-3063; 63629-8489; 63629-8491; 63629-8492; 64380-868; 68071-2206; 68788-7848; 68788-8199; 69097-813; 69097-815; 69844-055; 69844-056; 70010-228; 70518-2493; 70518-3103; 70518-3329; 70934-950; 70934-953; 71093-111; 71093-162; 71335-1199; 71335-1453; 71335-1997; 71335-2053; 71610-135; 71610-667; 72189-092; 72189-313; 72189-384; 72888-131; 76282-323; 80425-0035; 80425-0082; 80425-0150; 82009-072
UNII 6CW7F3G59X
Synonyms Gabapentin | 1-(Aminomethyl)cyclohexaneacetic Acid | Neurontin | Gabapentin Hexal | Convalis | Gabapentin-Ratiopharm | Gabapentin Ratiopharm | Novo-Gabapentin | Novo Gabapentin | NovoGabapentin | PMS-Gabapentin | Apo-Gabapentin | Apo Gabapentin | ApoGabapentin | Gabapentin Stada
Chemical Information
Molecular Formula C9H17NO2
CAS Registry Number 60142-96-3
SMILES C1CCC(CC1)(CC(=O)O)CN
Chemical Structure
ADRs Induced by Drug
*The priority for ADR severity classification is based on FAERS assessment, followed by the most severe level in CTCAE rating. If neither is available, it will be displayed as 'Not available'.
**The 'Not Available' level is hidden by default and can be restored by clicking on the legend twice.
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Weight decrease neonatal18.04.02.0070.000021%-
Rheumatoid vasculitis10.04.06.008; 15.01.03.006; 24.12.04.0220.000016%-
Prognathism15.10.05.0070.000026%-
Bradycardia neonatal02.03.02.019; 18.04.07.0040.000021%-
Palatal oedema07.05.04.0080.000031%-
Subacute cutaneous lupus erythematosus10.04.03.012; 15.06.02.012; 23.03.02.0200.000010%-
Hypertensive emergency24.08.01.0040.000042%-
Poor sucking reflex17.02.01.008; 18.04.04.0110.000026%-
Negative thoughts19.15.02.0120.000049%-
Sopor17.02.04.021; 19.02.04.0020.000146%-
Neonatal aspiration18.04.09.007; 22.11.01.0080.000010%-
Diffuse alveolar damage22.01.01.0190.000016%-
Communication disorder19.19.01.0080.000070%-
Foot deformity15.10.03.0050.000072%-
Psychotic disorder due to a general medical condition19.03.01.0080.000010%-
Myasthenia gravis crisis10.04.05.007; 15.05.08.004; 17.05.04.0070.000026%-
Sarcopenia15.05.06.0040.000010%-
Pruritus allergic10.01.03.046; 23.03.12.0100.000051%-
Accidental death08.04.01.013; 12.01.08.0400.000052%-
Tachyphrenia17.03.03.007; 19.10.03.0100.000026%-
Fear of death19.06.03.0060.000010%-
Apparent death08.01.03.0620.000010%-
Skin plaque23.03.03.0440.000016%-
Motor developmental delay17.01.02.023; 19.22.01.0050.000026%-
Bone deformity15.10.03.0060.000010%-
Neonatal behavioural syndrome15.05.04.020; 17.02.05.058; 18.04.04.010; 22.11.02.007---
Toxic leukoencephalopathy12.03.01.059; 17.13.02.0120.000010%-
Change in seizure presentation17.12.03.0220.000026%-
Disorganised speech17.02.08.017; 19.19.02.0050.000010%-
Fine motor skill dysfunction17.01.02.0200.000021%-
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ADReCS-Target
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